Gastritis H PyloriPhase 4HEPRANCT04769583
14-day Quadruple Therapy Versus Triple Therapy in HP Eradication
A Phase 4 study testing metronidazole based quadriple therapy in people with Gastritis H Pylori, run by mohamed bouchoucha at 1 site in Tunisia.
Trial summary
In this prospective randomized-controlled study, treatment-naive H. pylori-infected patients are randomized to receive either standard triple therapy or sequential therapy. The aim is to compare the efficacy of concomitant quadruple therapy with standard triple therapy as a first line treatment for H. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastritis H Pylori
- What is being tested?
- metronidazole based quadriple therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteTunisia
- Study dates
- 10 Feb 2019to 5 Mar 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged between 18 and 65, with documented Hp infection.
Who cannot join
- With Cirrhosis.
- With Renal failure (serum creatinine> 120 µmol / L).
- Having complicated peptic ulcer (stenosis or hemorrhage or perforation) in an acute phase.
- Having severe psychiatric disorders.
- Having had gastric surgery in their history.
- Having already received an HP eradication treatment.
Show all 9Show fewer
- Having received an antibiotic within the last two weeks.
- Who are allergic to one of the antibiotics used in the anti-Hp cure.
- Who are drug addicted.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind Randomized Study for Treatment of Helicobacter Pylori Infection: 14-day Non-bismuth Quadruple Therapy Versus Triple Therapy.
In this prospective randomized-controlled study, treatment-naive H. pylori-infected patients are randomized to receive either standard triple therapy or sequential therapy. The aim is to compare the efficacy of concomitant quadruple therapy with standard triple therapy as a first line treatment for H. pylori infection in Tunisian patients.
Read the detailed description
This study includes male and female patients aged between 18 and 65, with documented Hp infection and who have had no previous eradication treatment.The diagnosis of Hp infection was made through an anatomopathological study. Gastric biopsies were taken according to the Sydney protocol: two fundics in one pot, two antrals and one at the angle of the lesser curve in a second pot. The biopsies were studied by an experienced anatomopathologist.
The included patients were randomly divided into two treatment groups according to a 1: 1 ratio: the first group received concomitant quadruple therapy (QC) combining a double dose PPI (esomeprazole: 40 mg x 2 per day) with the amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days. The second group received triple therapy (TT) combining a double dose PPI (esomeprazole: 40 mg x 2 per day) with amoxicillin (1 g x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days.
- pylori eradication was assessed by the 13C-urea breath test 8 weeks after treatment.
- Conditions
- Gastritis H Pylori
- Being tested
- metronidazole based quadriple therapy, placebo based quadriple therapy
- Keywords
- Breath Tests, Helicobacter pylori
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metronidazole based quadriple therapyDrug
Also called concomitant quadruple therapy (QC)
patient randomized in QC will be treated by a double dose PPI (esomeprazole: 40 mg x 2 per day) in combination with amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day)
placebo based quadriple therapyDrug
Also called Triple therapy (TT)
patient randomized in TT will be treated by double dose PPI (esomeprazole: 40 mg x 2 per day) in combination with amoxicillin (1 g x 2 per day), clarithromycin (500 mg x 2 per day) and a placebo of metronidazole.
| Study group | Role | What they receive |
|---|---|---|
| concomitant quadruple therapy (QC) | Active comparator | PPI (esomeprazole: 40 mg x 2 per day) with the amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days Receives: Drug: metronidazole based quadriple therapy |
| triple therapy (TT) | Placebo comparator | PPI (esomeprazole: 40 mg x 2 per day) with amoxicillin (1 g x 2 per day) and clarithromycin (500 mg x 2 per day) AND PLACEBO for 14 days. Receives: Drug: placebo based quadriple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
HP eradiction rate
assessment by breath test
Measured: 6 weeks after completion of study treatment
Secondary outcomes (1)
percentage of adverse reactions
we will determinate the percentage of adverse reactions in each group of treatment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start10 Feb 2019
- Primary completion17 Feb 2020
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastritis H PyloriStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- mohamed bouchoucha
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, mohamed bouchoucha, Les Laboratoires des Médicaments Stériles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769583
- Sponsor's protocol ID
- TN2018-INT-INS-14
- Acronym
- HEPRA
- Status last verified
- Feb 2021
- First submitted
- 18 Feb 2021
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Randomized Study for Treatment of Helicobacter Pylori Infection: 14-day Non-bismuth Quadruple Therapy Versus Triple Therapy.
- ClinicalTrials.gov ID
- NCT04769583
- Acronym / sponsor ID
- HEPRA / TN2018-INT-INS-14
- Conditions
- Gastritis H Pylori
- Keywords
- Breath Tests, Helicobacter pylori
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- mohamed bouchouchaIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 17 Feb 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this prospective randomized-controlled study, treatment-naive H. pylori-infected patients are randomized to receive either standard triple therapy or sequential therapy. The aim is to compare the efficacy of concomitant quadruple therapy with standard triple therapy as a first line treatment for H. pylori infection in Tunisian patients.
Detailed description
This study includes male and female patients aged between 18 and 65, with documented Hp infection and who have had no previous eradication treatment.The diagnosis of Hp infection was made through an anatomopathological study. Gastric biopsies were taken according to the Sydney protocol: two fundics in one pot, two antrals and one at the angle of the lesser curve in a second pot. The biopsies were studied by an experienced anatomopathologist.
The included patients were randomly divided into two treatment groups according to a 1: 1 ratio: the first group received concomitant quadruple therapy (QC) combining a double dose PPI (esomeprazole: 40 mg x 2 per day) with the amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days. The second group received triple therapy (TT) combining a double dose PPI (esomeprazole: 40 mg x 2 per day) with amoxicillin (1 g x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days.
- pylori eradication was assessed by the 13C-urea breath test 8 weeks after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| concomitant quadruple therapy (QC) | Active comparator | Drug: metronidazole based quadriple therapyPPI (esomeprazole: 40 mg x 2 per day) with the amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days |
| triple therapy (TT) | Placebo comparator | Drug: placebo based quadriple therapyPPI (esomeprazole: 40 mg x 2 per day) with amoxicillin (1 g x 2 per day) and clarithromycin (500 mg x 2 per day) AND PLACEBO for 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients aged between 18 and 65, with documented Hp infection.
Key exclusion criteria (9 listed)
- With Cirrhosis.
- With Renal failure (serum creatinine> 120 µmol / L).
- Having complicated peptic ulcer (stenosis or hemorrhage or perforation) in an acute phase.
- Having severe psychiatric disorders.
- Having had gastric surgery in their history.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metronidazole based quadriple therapyAlso: concomitant quadruple therapy (QC)patient randomized in QC will be treated by a double dose PPI (esomeprazole: 40 mg x 2 per day) in combination with amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day) | Drug | concomitant quadruple therapy (QC) |
| placebo based quadriple therapyAlso: Triple therapy (TT)patient randomized in TT will be treated by double dose PPI (esomeprazole: 40 mg x 2 per day) in combination with amoxicillin (1 g x 2 per day), clarithromycin (500 mg x 2 per day) and a placebo of metronidazole. | Drug | triple therapy (TT) |
Primary outcome
HP eradiction rate
Time frame: 6 weeks after completion of study treatment
assessment by breath test
1 secondary outcome
percentage of adverse reactions
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing metronidazole based quadriple therapy in people with Gastritis H Pylori, run by mohamed bouchoucha at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HP eradiction rate (time frame: 6 weeks after completion of study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.